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    Summary
    EudraCT Number:2005-005660-86
    Sponsor's Protocol Code Number:06_DOG03_107
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2006-07-23
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2005-005660-86
    A.3Full title of the trial
    A Phase II, open label, single arm study to evaluate Ticilimumab in Advanced Gastric/Oesophageal Adenocarcinoma
    A.4.1Sponsor's protocol code number06_DOG03_107
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorChristie Hospital NHS Trust
    B.1.3.4CountryUnited Kingdom
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Information not present in EudraCT
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameTicilimumab
    D.3.2Product code CP-675, 206
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTicilimumab (fully human IgG2 monoclonal antibody)
    D.3.9.1CAS number 745013-59-6
    D.3.9.2Current sponsor codeCP-675, 206
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) Yes
    D.3.11.7Plasma derived medicinal product Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    D.3.11.9Recombinant medicinal product Information not present in EudraCT
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Advanced Gastric/Oesophageal Adenocarcinoma
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the antitumour-efficacy, as determined by objective response rate, of intravenous ticilimumab administered at a dose of 15mg/kg every 90 days to patients with advanced or metastatic gastric or oesophageal adenocarcinoma
    E.2.2Secondary objectives of the trial
    Clinical
    • To assess additional evidence of anti-tumour activity as measured by best on-study response rate, durable response rate, duration of response, progression-free survival and overall survival (see section 14.5 for definitions)
    • To characterize the safety profile and tolerability of ticilimumab in this setting
    Laboratory
    • To assess IL2 release in response to SEA
    • To assess the changes in lymphocyte immunophenotype following ticilimumab
    • To evaluate immune responses to 5T4 tumour associated antigen following ticilimumab
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    To be eligible for the study, patients must satisfy all of the following criteria:
    1. Histologically confirmed gastric or oesophageal adenocarcinoma that is locally advanced or metastatic.
    2. Prior treatment with appropriate chemotherapy.
    3. Patients with persistent or progressive disease post chemotherapy or patients who could not tolerate previous treatment due to unacceptable toxicity.
    4. A minimum of one measurable lesion on CT scan according to RECIST. See Appendix 2 for details.
    5. ECOG performance status (PS) 0 or 1.
    6. Life expectancy > 3 months.
    7. Age ≥ 18 years.
    8. Female patients must be surgically sterile or be postmenopausal for at least two years, or must agree to use effective contraception during the period of treatment and 6 months after. Women of child bearing potential must have a negative pregnancy test prior to entry and within 72 hours prior to receiving each cycle of ticilimumab.
    9. Adequate bone marrow, hepatic and renal function determined within 14 days prior to enrollment, defined as:
    • Absolute neutrophil count ≥ 1.5 x 109 cells/L
    • Platelets ≥ 100 x 109 cells/L
    • Haemoglobin ≥ 9.0g/dL
    • Aspartate and Alanine aminotransferases (AST, ALT) ≤ 2.5 x ULN 5 x ULN if documented liver metastases are present)
    • Total bilirubin ≤ 2 x ULN (except for patients with documented Gilbert’s syndrome)
    • Serum creatinine ≤170μmol/L
    10. Patients must have recovered from all prior treatment-related toxicities, to baseline status, or to NCI CTCAE v3 Grade 0 or 1, except for toxicities not considered a safety risk such as alopecia or residual peripheral neuropathy resulting from prior systemic therapy. Post-surgical pain shall not be considered a basis for exclusion.
    11. Must be willing and able to provide written informed consent.
    12. Must be willing and able to comply with Study procedures
    E.4Principal exclusion criteria
    1. Received treatment for cancer within 4 weeks prior to enrollment (dosing), 12 weeks for immunotherapy.
    2. Received any prior anti-CTLA4-inhibiting agent.
    3. History of, or significant evidence of risk for, chronic inflammatory or autoimmune disease (eg Addison’s disease, multiple sclerosis, Graves disease, Hashimoto’s thyroiditis, inflammatory bowel disease, psoriasis, rheumatoid arthritis, systemic lupus erythematosus, hypophysitis, pituitary disorders etc.). Vitiligo will not be a basis for exclusion.
    4. History of, or clinically apparent hepatitis B or hepatitis C.
    5. History of inflammatory bowel disease, celiac disease or other chronic gastrointestinal conditions associated with diarrhoea or bleeding, or current acute colitis of any origin.
    6. Potential requirement for systemic corticosteroids or concurrent immunosuppressive drugs based on prior history or received systemic steroids within the last 4 weeks prior to enrollment (Note: inhaled or topical steroids in standard doses are allowed).
    7. Known brain metastases.
    8. Prior or concurrent malignancy within the last 5 years other than basal cell carcinoma or in situ carcinoma of the uterine cervix.
    9. Evidence of uncontrolled cardiac or respiratory disease or other serious medical or psychiatric disorders that would be a contra-indication to study procedures.
    10. Evidence of significant clinical disorder or laboratory finding which, in the opinion of the investigator makes it undesirable for the patient to participate in the study.
    11. Pregnancy or breast-feeding.
    E.5 End points
    E.5.1Primary end point(s)
    Best Overall Response (BR) based on Response Evaluation Criteria in Solid Tumours (RECIST)1 and defined as the proportion of patients with a confirmed complete response (CR) or partial response (PR) relative to the total number of evaluable patients.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Information not present in EudraCT
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.3Elderly (>=65 years) Information not present in EudraCT
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others Information not present in EudraCT
    F.4 Planned number of subjects to be included
    F.4.1In the member state
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2006-07-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-04-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-08-05
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